FDA.reportPublic FDA data

Simply Harmony

Manufacturer
Nartex Laboratorios Homeopaticos, S.A. De C.V.
Effective date
2021-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:15:13

Label at a glance#

ProductSimply Harmony
Active ingredientPASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, DIBASIC POTASSIUM PHOSPHATE, STRYCHNOS IGNATII SEED
Label structure9 sections

Indications and uses

For the temporary relief of mental fatigue, difficulty concentrating, headaches, and occasional sleeplessness due to everyday stress. For hard-day periods. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Dosage and administration

adults and children 12 years and older: take 1 tablet every 8 hours. Dissolves slowly in mouth. children under 12 years, consult a physician.

Storage and handling

store in a cool and dry place. do not use if container seal is broken.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ignatia amara 3X HPUS*

Passiflora incarnata 3X HPUS*

Valeriana officinalis 3X HPUS*

Kali phosphoricum 6X HPUS*

Purpose

OTC - PURPOSE SECTION

Ignatia amara 3X HPUS*.................................Headache, mental fatigue and insomnia from emotional disorders

Passiflora incarnata 3X HPUS*........................Sleeplessness from worries and restlessness

Valeriana officinalis 3X HPUS*........................Restless sleep

Kali phosphoricum 6X HPUS*.........................Mental fatigue, difficulty concentrating, headaches, occasional sleeplessness

*The letters "HPUS" indicate that the compoennts in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is a homeopathic dilution. See www.nartexlabsusa.com for more information.

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of mental fatigue, difficulty concentrating, headaches, and occasional sleeplessness due to everyday stress. For hard-day periods. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

  • if you have an allergy or hypersensitivity to the components of the formula or have had a prior reaction to this product.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • conditoin worsens.
  • symptoms persist for more than 7 days or clear up and occur again within a few days.
  • rash develops.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, consult a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older: take 1 tablet every 8 hours. Dissolves slowly in mouth.
  • children under 12 years, consult a physician.

Other information

STORAGE AND HANDLING SECTION

  • store in a cool and dry place.
  • do not use if container seal is broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Gelatin, Lactosa USP, Magnesium stearate, Potato starch, Purified water, Sodium benzoate, Talc USP

Questions or comments?

OTC - QUESTIONS SECTION

informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST. Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 34666-403-01

SIMPLY Harmony

Mental Fatigue Relief

  • Stay Calm
  • Stay Sharp
  • Stay Focused
  • Mood Support

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

Homeopathic

120 Tablets

11

22

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-403-01Simply Harmony120 in 1 BOTTLETABLET1201
34666-403-01Simply Harmony1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34666-403SIMPLY HARMONY (IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, KALI PHOSPHORICUM) TABLET [NARTEX LABORATORIOS HOMEOPATICOS, S.A. DE C.V.]1Current NDC, Legacy NDC, 2 package rows20211216_d244bc14-51d2-2c4c-e053-2995a90a63a9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34666-40334666-403-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
STARCH, POTATO8I089SAH3TIACT
TALC7SEV7J4R1UIACT
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
VALERIANJWF5YAW3QWACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
GELATIN2G86QN327LIACT
MAGNESIUM STEARATE70097M6I30IACT
STRYCHNOS IGNATII SEED1NM3M2487KACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simply HarmonyIGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, KALI PHOSPHORICUMNartex Laboratorios Homeopaticos, S.A. De C.V.d244bc14-51d2-2c4c-e053-2995a90a63a92021-12-03WarningsExact identifier
ndc (package): 34666-403-01
ndc (product): 34666-403
ndc11 (package): 34666040301
spl id: d244bc14-51d3-2c4c-e053-2995a90a63a9
spl set id: d244bc14-51d2-2c4c-e053-2995a90a63a9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.